Cefdinir

Product NDC: 50090-1033
Requested package NDC: 50090-1033-3
11-digit product format: 500901033
Labeler code: 50090
Product ID: 50090-1033_2b8b8acc-40d9-4992-9c3b-e5f145951211
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065264
Marketing category: ANDA
Marketing start: 2006-05-30
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-1033	50090-1033-3	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1033	50090-1033-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1033	50090-1033-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065264-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2006-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065264-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefdinir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CI0FAO63WC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1033-0	2023-02-07	CEFDINIR CAPSULES USP
50090-1033-1	2023-02-07	CEFDINIR CAPSULES USP
50090-1033-2	2023-02-07	CEFDINIR CAPSULES USP
50090-1033-3	2023-02-07	CEFDINIR CAPSULES USP
50090-1033-0	2023-01-30	CEFDINIR CAPSULES USP
50090-1033-1	2023-01-30	CEFDINIR CAPSULES USP
50090-1033-2	2023-01-30	CEFDINIR CAPSULES USP
50090-1033-3	2023-01-30	CEFDINIR CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-1033-0	Cefdinir	10 in 1 BOTTLE	CAPSULE	10	11
50090-1033-1	Cefdinir	20 in 1 BOTTLE	CAPSULE	20	11
50090-1033-2	Cefdinir	14 in 1 BOTTLE	CAPSULE	14	11
50090-1033-3	Cefdinir	30 in 1 BOTTLE	CAPSULE	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1033-0	EA - Each	50090-1033	cb6fc725-99fd-4002-ba74-c8d6f9b2fe43	1	2023-06-06
50090-1033-1	EA - Each	50090-1033	e81f6577-53ed-483c-a97b-82ea31d1e72e	1	2021-08-05
50090-1033-2	EA - Each	50090-1033	c419610d-de77-4035-8be5-0168ac7c30ab	1	2021-08-05
50090-1033-3	EA - Each	50090-1033	79bd886d-ae44-4894-af7b-c828115578d1	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1033	CEFDINIR CAPSULE [A-S MEDICATION SOLUTIONS]	11	Current NDC, Legacy NDC, 4 package rows	20250403_12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals, Inc.	8787ea15-bf90-4178-9b0f-08b075f1aa3d	2026-03-24	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	cb7366ce-1778-451f-aba5-65cf73c9b87a	2025-10-14	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	2025-08-20	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	A-S Medication Solutions	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	2025-04-01	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264 ndc (package): 50090-1033-3 ndc (product): 50090-1033 ndc11 (package): 50090103303

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CI0FAO63WC	CEFDINIR	91832-40-5	CEFDINIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200346	cefdinir 300 MG Oral Capsule	PSN	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	11
200346	cefdinir 300 MG Oral Capsule	SCD	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1033-3	50090103303	30 CAPSULE in 1 BOTTLE (50090-1033-3)	30 capsule	2019-10-09	0000-00-00	No	No	Current